Follow-up Study of Population Vaccinated With COVID-19 Vaccine

Healthy Clinical Trial

Official title:

Follow-up Study of Population Vaccinated With COVID-19 Vaccine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972591
• Other study ID #: TJ20210623
• Status: Recruiting
• Start date: March 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2021
• Source: Tongji Hospital
• Contact: Qin Ning, Professor
• Phone: +8613971521450
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A multi-centered clinical follow-up study to investigate the long-term dynamic of COVID-19 antibody level after vaccination.

Description:

From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. As of July 6, 2021, more than 180 million confirmed cases and around 4 million deaths have been reported globally. Till now, many treatment methods has gradually formed a consensus. At the same time, several domestic vaccines have been offered to the public for free inoculation in our country. However, due to the urgent form of the epidemic, the short vaccine development cycle and heavy tasks, there is no clear conclusion on the long-term changes in antibody levels after vaccination.Therefore, we plan to carry out a multi-center prospective observational trial to better understand the dynamic changes of the antibody levels in patients after vaccination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (18 years old or elder) who prepare or have been vaccinated against COVID-19, and has not participated in similar clinical studies.

Exclusion Criteria:

• People who are allergic to any active ingredient of the vaccine, any inactive ingredient which was used in the production process, or those who have been allergic to the same kind of vaccine before.
• People who have had severe allergic reaction to vaccine before (such as acute allergic reaction, vascular neuroedema, dyspnea, etc.)
• People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.)
• People who are feverish, or suffering from acute diseases, or suffering from acute episodes of chronic diseases, or with serious chronic diseases without control.
• Pregnant woman
• Juvenile

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
China	Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (10)

Lead Sponsor	Collaborator
Qin Ning	First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital Xi'an Jiaotong University, Shanxi Bethune Hospital, Shiyan Renmin Hospital, The second Hospital of JingZhou, WUHAN NO.7 HOSPITAL, Xiangya Hospital of Central South University, Yichang Central Hospital., Yunnan Provincial Infectious Disease Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms and signs	symptoms and signs after vaccination will be collected	6months
Primary	antibody levels	antibody levels will be collected	6months
Primary	laboratory findings	Clinical laboratory examination were obtained during follow-up.	6months